Kornimate/medical-research-clean huggingface dataset:
positive therapy for autonomic function & mood in icd patients

Conditions: Ventricular Arrhythmia; Implantable Cardioverter Defibrillator

Summary: the purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (quality of life therapy) modified specifically for patients with implantable cardioverter defibrillator (icd); and 2) obtain estimates of effect size for qolt compared to heart healthy education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 \& 9-months). it is hypothesized that the qolt will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.


Eligibility criteria:
inclusion criteria: 1. adult men and women (≥18 years of age) who have received an icd for primary or secondary prevention of sudden cardiac death. all patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. there is no requirement for time since implant; 2. score ≥5 on the hospital anxiety and depression scale (hads) anxiety or depression scales; 3. able to read and write english 4. able to commit to the 3-month qolt/hhe program and 3 assessments over a 9-month duration. exclusion criteria: 1. \>5% atrial or ventricular pacing; 2. sinus node dysfunction; 3. persistent and permanent atrial fibrillation (af) (h/o of paroxysmal af will be allowed). 4. long qt syndrome; and other channelopathies such as brugada syndrome; 5. hypertrophic cardiomyopathy; 6. neurocognitive or cognitive impairments; 7. severe psychopathology that warrants intensive treatment; 8. participation in another research trial; and 9. currently in psychological or psychiatric treatment. 10. current psychotropic and cardiac medication prescriptions and usage need to be stable (i.e., no change in type or dosage) for 3-months prior to study enrollment.

Keywords: psychological wellbeing anxiety depression autonomic functioning
the effect of degree of rice-polishing on glycaemic response

Conditions: Diabetes Mellitus; Obesity

Summary: to investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy chinese male volunteers.

there will be a total of 8 test session. each session will last for 3.5 hours. at each test session, volunteers will be served with test meal and blood will be collected. after an overnight fast, subjects will visit the research center. two fasting capillary blood samples will be collected via fingerprick. following the fasting samples, subject will consume the test meals. further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. these samples will be used to analyses for whole capillary blood glucose. at every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.

Eligibility criteria:
inclusion criteria: * male * chinese ethnicity * age ≥21 and ≤ 60 years * body mass index between 18.5 to 25 kg/m2 * normal blood pressure =\<140/90 mmhg * fasting blood glucose \<6.0 mmol/l * in general good health exclusion criteria: * current smoker * have any metabolic diseases (such as diabetes, hypertension etc) * do not have known glucose-6-phosphate dehydrogenase deficiency (g6pd deficiency) * have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics) * have intolerances or allergies to any foods * currently partake in sports at the competitive and/or endurance levels * intentionally restrict food intake
nutrition product combine with continuous glucose monitoring in gestational diabetes mellitus patients

Conditions: SANZ®KINGWILL Combined With CGM Equipment in GDM Patients; GLUCERNA SR® Combined With CGM Equipment in GDM Patients

Summary: a prospective, multicenter, randomized controlled trial including about 60 gestational diabetes mellitus patients (gdm) in beijing will be included to evaluate the effectiveness and safety of nutrition product (sanz®kingwill) in gdm patients, based on continuous glucose monitoring (san meditech cgm-303).

this study will recruit pregnant women who were diagnosed as gdm by 75g oral glucose tolerance test (ogtt) in 2nd trimester and followed up for 1month. a total of 60 gdm patients were expected to be enrolled. using the double-blind method, they were randomly divided into two groups: experimental group and control group. both of the two groups were provided medical nutrition treatment by nutritionist after gdm was diagnosed and cgm equipment (san meditech cgm-303) was worn. blood and urine samples were collected. at the following two days, oatmeal (shizhuang) was used as extra meal at 10:00am and 15:00pm in both groups. in the next 4 weeks experimental group was provided with the domestic nutrition product (sanz®kingwill), while existing products (glucerna sr®) for control group as their extra meals at 10:00am and 15:00pm. in the last day, cgm equipment (san meditech cgm-303) was removed and blood and urine samples were collected.

Eligibility criteria:
inclusion criteria: * 1. women aged 22 to 40 years old 2. diagnosed as gestational diabetes mellitus 3. signed informed consent exclusion criteria: * 1. gdm patient who is no longer suitable to continue pregnancy. 2. patients who use any hypoglycemic drugs or any type of similar products. 3. patients who have diseases severely affected the nutrition product digestion and absorption. 4. patients with severe heart, liver, kidney dysfunction, mental retardation, dyscrasia, etc. 5. patients who cannot tolerate enteral nutrition. 6. patients with other conditions which investigator believes they are not eligible for this study.

Keywords: nutrition product continuous glucose monitoring gestational diabetes mellitus
low-pv continuation

Conditions: Polycythemia Vera

Summary: this multicenter longitudinal observational study focuses on italian patients with polycythemia vera (pv) who were enrolled in the low-pv rct and continued receiving ropeginterferon alfa-2b until the study's conclusion on march 31, 2023. it includes patients who were responders to ropeginterferon alfa-2b after two years in the phase ii randomized trial "low-pv." data will be collected retrospectively every 6 months from march 31, 2023 to november 30, 2024 and prospectively from december 1, 2024 to march 31, 2026.

multicentre longitudinal observational italian study of patients with polycythemia vera (pv) enrolled in low-pv rct and still receiving the experimental drug (i.e., ropeginterferon alfa-2b) at study end (31-03-2023). thirty-six patients who completed the low-pv rct and were responders to interferon, continued treatment with the drug and are followed at their respective centers in italy. the "low-pv continuation" study aims to collect after 1,2,3 years the data on these patients, regardless of the treatment they were undergoing at the time of enrollment in the current study, after their informed consent. in details, data will be collected retrospectively from march 31, 2023 to november 2024 and prospectively from december 1, 2024 to march 31, 2026. given the descriptive nature of the study, no formal statistical hypothesis will be made.

Eligibility criteria:
inclusion criteria: * patients enrolled in the low-pv rct study who continued to receive ropeginterferon alfa-2b until the conclusion of the study on march 31, 2023. these patients will be included regardless of the treatment they are undergoing at the time of enrollment in the current study. * patients who have signed the written informed consent for study participation. exclusion criteria: * none

Keywords: ropeginterferon alfa-2b
efficacy and safety evaluation of bcma-ucart

Conditions: Multiple Myeloma

Summary: this trial aims to evaluate the safety and efficacy of bcma-ucart in treating patients with relapsed or refractory multiple myeloma.

bcma(b-cell maturation antigen) is a tumor antigen of multiple myeloma. using a genetic engineering strategy to assemble an anti-bcma car(chimeric antigen receptor) in t cells will help these cart cells to recognize and kill bcma-expressing mm tumor cells. bcma-ucart is a kind of allogeneic cart, originating from t cells of health donors. this open-label, dose-escalation study aims to evaluate the safety and anti-tumor efficacy of bcma-ucart in treating relapsed or refractory multiple myeloma.

Eligibility criteria:
inclusion criteria: * have the capacity to give informed consent; * confirmed diagnosis of active mm as defined by nccn and imwg criteria; * have a diagnosis of bcma+ multiple myeloma (mm), (≥ 5% bcma+ in cd138+ plasma cells by flow cytometry obtained within 45 days of study enrollment); * refractory and relapsed mm patients after \> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (asct); * ecog score=0-2. * subjects according with any of the following options: * age≥50; * failure with separation of t cells during autologous cart processing; or, * failure with expansion of autologous cart; or, * the proportion of t cells in pbmc \<10%; or, * won't benefit from autologous cart therapy because of disease progress. exclusion criteria: * pregnant or nursing women; women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy * active infection, hiv infection, syphilis serology reaction positive; * active hepatitis b, hepatitis c at the time of screening * significant hepatic dysfunction as following, sgot(serum glutamic-oxaloacetic transaminase)\> 5 x upper limit of normal; bilirubin \> 3.0 mg/dl; * lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis * serious mental disorder; * with severe cardiac, liver, renal insufficiency, diabetes and other diseases; * participate in other clinical research in the past three months; previously treatment with any gene therapy products * contraindication to cyclophosphamide or fludarabine chemotherapy
therapeutic study of prostatitis with elevated psa

Conditions: Prostatitis; PSA

Summary: this clinical study was mainly aimed at exploring the efficacy of herbal medicine (huange capsule) in the treatment of patients with prostatitis with elevated psa. the main questions it aims to answer are: 1. to evaluate the influence and exact curative effect of huange capsule on serum psa level of patients with psa-elevated prostatitis, to improve the specificity of psa and reduce unnecessary puncture biopsy. 2. to provide evidence-based evidence for clinical efficacy evaluation subjects will be randomized to a routine regimen with or without the use of huangge capsules. to evaluate whether the efficacy of the conventional treatment combined with huange capsule group was superior to that of the conventional medication group.


Eligibility criteria:
inclusion criteria: 1. compliant with the diagnostic criteria of both chinese and western medicine for prostatitis; 2. serum psa increases, ranging from 4 ng/ml to 10 ng/ml; 3. male, aged between 18 and 80 years old: 4. b-ultrasound and imaging examination fail to consider the front row cancer; 5. i have not taken any chinese or western medicine for the treatment of prostatitis in the past two weeks; 6. those who have signed the informed consent form. exclusion criteria: 1. patients with frequent micturition caused by combined sexually transmitted diseases and urinary tract infection; 2. oliguria or anuria caused by urinary calculi, prostate cancer, and acute and chronic renal failure; 3. dysuria caused by neurogenic bladder collapse, bladder neck collapse fibrosis, and urethral stricture; 4. the residual urine volume \> 150ml: 5. losers of invasive treatment of benign prostatic obstruction; 6. patients with pelvic surgery or injury history that affected the local internal organs, muscles, nerves and other functional states; 7. b-ultrasound shows obvious bladder diverticulum or upper urinary tract obstruction caused by bph, with impaired renal function; 8. patients with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver and hematopoietic system, refractory diabetes mellitus, or diabetic neuropathy and psychosis; 9. patients with serum t-psa\>10ng/ml.
a study of single dose pain therapy in patients with painful diabetic neuropathy (0000-115)

Conditions: Painful Diabetic Neuropathy

Summary: the purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin * patient has pain in both feet that occurred after onset of diabetes * patient agrees to maintain a consistent activity level throughout the study * patient is not on chronic pain therapy, or is on a stable dose of one pain therapy * female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study * patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study exclusion criteria: * patient has a history of congestive heart failure * patient has/had a seizure disorder * patient has tried and failed 3 or more drugs to treat neuropathic pain * patient is currently taking pregabalin or duloxetine hydrochloride * patient has had a malignancy within the past 2 years (excluding basal cell carcinoma) * patient has history of hepatitis b or c or hiv infection * patient has skin-condition that may decrease sensitivity in area of neuropathic pain
the incidence of hepatitis b reactivations in patients affected by chronic lymphocytic leukemia with ibrutinib

Conditions: Chronic Lymphocytic Leukemia

Summary: this observational retrospective study will enroll at least 158 patients affected by chronic lymphoid leukemia (cll) with previous hbv exposure (hbsag negative, anti-hbc positive with or without anti-hbs) treated with ibrutinib single agent according to the iwcll criteria 2008. patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. each patient will be observed for one year from the first administration of ibrutinib.

this observational retrospective study will enroll at least 158 patients affected by cll with previous hbv exposure (hbsag negative, anti hbc positive with or without anti-hbs) treated with ibrutinib single agent according to the iwcll criteria 2008. patients will be divided in two cohorts one encompassing patients receiving lamivudine and the second one including patients who will not be given any prophylaxis. each patient will be observed for one year from the first administration of ibrutinib. the aim of the study is to evaluate the incidence of hbv reactivation cases in patients affected by cll treated with ibrutinib.

Eligibility criteria:
inclusion criteria: * cll/small lymphocytic lymphoma (sll) patients. * patients treated with single-agent ibrutinib (at least one dose) outside interventional clinical trials before january 31, 2019. * serology positive with previous hbv/obi (hbsag negatives, anti-hbc positives with or without anti-hbs) infection. * signed written informed consent, if applicable, indicating study scope and procedure understanding. exclusion criteria: * patients who did not undergo hepatitis b screening before starting the ibrutinib therapy. * patients affected by cll treated with ibrutinib vaccinated against hepatitis b or with serology not compatible with a previous infection. * patients affected by hcv, hiv or with other causes of liver disease. * patients enrolled in clinical trials including ibrutinib administered in combination with other drugs. * patients positive for active hepatitis b.

Keywords: chronic lymphocytic leukemia hepatitis b ibrutinib
clinical validation of tele-stethoscope system digital

Conditions: Respiratory Disorder; Heart Disorder

Summary: acute respiratory infections and other respiratory and cardiology diseases like copd or heart failure are important causes of morbidity and mortality around the world. telemedicine is defined as the delivery of health care and the sharing of medical knoledge over distances using telecommunication systems. inexpensive techologies offer the possibility of a direct, real-time connection between the patient or the other end. these technologies help to the physicians to manage different symptoms and cardio-respiratory diseases. a real-time wireless tele-stethoscopy system was designed to allow a physician to receive real-time cardio-respiratory sounds from a remote auscultation, as well as video images showing where the technician is placing the stethoscope on the patient´s body. actually, the lack of physicians in rural areas of developing countries makes difficult their correct diagnosis and treatment. furthermore, in the majority of health systems, the patients are shared between primary care and medical specialty in hospitals. the tele-stethoscopy system through telemedicine could help to the physicians or health-care technicians in the majority of health systems and especially in rural areas of developing countries without physicians to manage the patients. for this reason, the goal of this project is the clinical validation of an open real-time tele-stethoscope systme (ehas-fundatel digital stethoscope) previously designed, with different specialist (pneumologists, cardiologists and internists.)


Eligibility criteria:
inclusion criteria: * informed consent sign. * pacient admitted to hospital with any disease but no inestable disease. exclusion criteria: * the lack of informed consent. * inestable disease.

Keywords: telemedicina respiratory sounds tele-stethoscopy wireless real-time e-health heart sounds
effect of tactile and kinesthetic stimulation on very low birth weight preterm infants

Conditions: Preterm Birth

Summary: two groups of preterm infants with birth weight equal to or less than 1500 grams will be studied. one group will receive the standard care and the other will receive standard care plus maternal special tactile stimulation. gain of weight, length and head circumference, date of the beginning of enteral feedings, length of time to recover birth weight and age of hospital discharge will be recorded and compared between both groups.

preterm infants birth weight equal or less than 1500 grams and gestational age equal or less than 32 weeks will be randomized in two groups: standard care that will receive the usual treatment applied to all infants admitted to our unit and a second groups that will receive standard care plus maternal tactile and kinesthetic stimuli that will be taught to the mothers. randomization will be performed among those that accept to participate in the study. growth (birth, length and head circumference), age of life to start receiving enteral feedings, length of hospital stay, time to recover birth weight will be recorded and compared between both groups.

Eligibility criteria:
inclusion criteria: * preterm newborns with birth weight equal to or less than 1500 grams and gestational age equal to or less than 32 weeks. * mother willing to participate in study. exclusion criteria: * major congenital malformations * congenital infectious diseases * mother not willing to participate in study
a study to evaluating the pharmacokinetics, safety, and efficacy of atg 016 monotherapy in ipss-r intermediate risk and above myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndrome

Summary: this is a phase ⅰ/ii, open-label study to investigate the pharmacokinetics, safety, and efficacyof atg 016 monotherapy in ipss-r intermediate risk and above myelodysplastic syndrome (mds) patients after failure of hypomethylating agent (hma)-based therapy.

this is a phase ⅰ/ii, open-label study to investigate the pharmacokinetics, safety, and efficacyof atg 016 monotherapy in ipss-r intermediate risk and above myelodysplastic syndrome (mds) patients after failure of hypomethylating agent (hma)-based therapy. in phase i: approximately 15 to 21 subjects and phase ii: approximately 44 subjects; approximately 59 to 65 subjects will be enrolled totally in this study.

Eligibility criteria:
inclusion criteria: 1. understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. 2. ≥18 years of age, males or females. 3. eastern cooperative oncology group (ecog) performance status of ≤2. 4. a life expectancy longer than 3 months in the opinion of the investigator at the screening. 5. male subjects (including those who have received vasectomy) must agree to use condoms during sex with a woman of childbearing age and have no plans to impregnate the woman throughout the study and for 3 months following the last dose after the date of signing the icf. exclusion criteria: 1. history of central nervous system (cns) involvement. 2. toxicity from prior antitumor therapy did not return to grade 1 or baseline (except for alopecia, neutropenia, anemia, and thrombocytopenia. for neutrophils, hemoglobin, and platelets, please follow exclusion criteria no. 5). 3. history of human immunodeficiency virus (hiv) infection. 4. history of severe bleeding disorder, such as hemophilia a, hemophilia b, and vascular hemophilia. 5. history of allogeneic stem-cell transplantation. 6. serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent. 7. pregnant or lactating women.
transcranial magnetic stimulation (tms) in binge eating disorder (bed)

Conditions: Binge-Eating Disorder

Summary: this study evaluates de efficacy of 5hz repetitive transcranial magnetic stimulation (rtms) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.

binge eating disorder (bed) affects a significant percentage of de national population (1.4%) in a portio 2-1 in woman compared with men, the repetitive transcranial magnetic stimulation (rtms) is a neuromodulation technique, which allows us to induce brain electrical activity by plating magnetic fields and it has been proven that at 10hz it has an effect of improvement in the craving of food.

Eligibility criteria:
inclusion criteria: 1. subjects of both sexes. 2. subjects from 18 to 45 years of age. 3. subjects with diagnosis of binge eating disorder. 4. subjects without changes in pharmacological treatment in the last 30 days. 5. subjects who agree to sign the informed consent letter. exclusion criteria: 1.subjects with a history of traumatic brain injury with loss of consciousness. 2.subjects with intracranial metallic objects or metal plates in the skull. 3.subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases). 4.patients with psychotic symptoms, bipolar affective disorders and substance dependence. 5.subjects with alterations in electroencephalogram (epileptiform activity). 6.patients with any type of chronic or neurological medical disease not controlled.

Keywords: binge eating disorder transcranial magnetic stimulation food craving